Start Up Associate

hace 3 días

Buenos Aires, Argentina Labcorp A tiempo completo

Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team.

Essential Job Duties:
 Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance

 Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines

 Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.

 With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.

 May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.

 Escalate study issues appropriately and in a timely fashion.

 Update study documents when there are changes in study personnel/study amendments.

 Contribute to the preparation of submissions to IRB/IEC with appropriate supervision.

 Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.

 Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.

 Perform other duties as assigned by management.

Experience

Minimum Required:
 Minimum 0 - 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

 Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process

Education/Qualifications/Certifications and Licenses Recommended:
Level of education preferred (if required or experience level which may be substituted for level of education).

Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).

 University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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